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Clinical Trials/CTRI/2017/05/008566
CTRI/2017/05/008566Not yet recruitingPhase 1/2

Study of BEST device for scar treatment and joint pain relief

Avazzia Inc2 sites in 1 country40 target enrollmentStarted: January 6, 2017Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Enrollment
40
Locations
2
Primary Endpoint
ii) Relief of knee joint pain

Study Overview

Brief Summary

Studiesand research are ongoing for the appropriate treatment of scar. Electricalstimulation is one of the approached modality. In the project, this modalitywill be used with an additional feature of biofeedback through the use of thedevice, Pro-Sport with BEST (Biofeedback Electro-Stimulation Technology)developed by Avazzia for scar treatment. Several parameters associated withscar and scar with pain are taken into consideration. The different parameterschanges taking place throughout the course of the treatment are to be studied.

Almostevery individual has a scar on their body. Some may be proud of it while somewould want to get rid of it. However, the present available treatments may ormay not be ineffective to all types of scars. Therefore, for the project, thepopulation on which the treatment is to be done is kept open i.e., anyindividual with any type of scar and even scar associated with pain can takepart in the study. The treatment is done on a regular basis.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • i) Subjects with any type of scar OR ii) Subjects with scar associated with pain.

Exclusion Criteria

  • i) Subjects below 18 years of age ii)Subjects who are pregnant, with implanted pacemaker or any such devices ii) Subjects with any neurological conditions.

Outcomes

Primary Outcomes

ii) Relief of knee joint pain

Time Frame: 3 months duration

i) Evaluating the functionality of the device

Time Frame: 3 months duration

iii) Scar reduction

Time Frame: 3 months duration

iv) Publications to highlight the pros and cons of the device

Time Frame: 3 months duration

Secondary Outcomes

  • i) Evaluating the functionality of the device(ii) Relief of knee joint pain)

Investigators

Sponsor Class
Other [Health & Wellness Device Manufacturing Company]

Study Sites (2)

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